MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Catalog Number 629029

Device Problems Installation-Related Problem (2965); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Eye Injury (1845)

Event Date 02/07/2016

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) evaluated the instrument at the customer's site on (b)(4) 2016.The fse reported that the customer was walking near the instrument where the waste disposes to the laboratory facility's waste drain when the customer was sprayed by the waste fluid.The fse surmised that it was the pressure from the waste tubing that caused it to disconnect from its attachment at the laboratory facility's drain.He explained that the waste tubing from both a dxh800 and a dxhsms (slide maker stainer) were inserted into a metal pipe which leads to the laboratory facility's drain.The fse found that the customer had not secured the two waste tubes into the metal pipe at the laboratory facility's drain per the instructions for use, which is considered operator use error.The fse noticed that since the incident, facilities had secured the waste tubing to the metal pipe to prevent movement and the metal pipe has been stabilized in the center of the waste area with a cover on top to minimize splashing.The operator's date of birth, age, and weight were not provided by the customer.(b)(4).

Event Description

The customer indicated that she had been sprayed in the face and the eyes by waste from a unicel dxh 800 coulter cellular analysis system.The volume of the fluid was approximately 10 ml of instrument waste.The customer was walking near the laboratory facility's waste drain area and was not wearing personal protective equipment (ppe) at the time of the event.The affected operator required medical attention and was evaluated at the local emergency room.It was determined by the physician that the operator sustained an irritation to the right eye which caused blurred vision in the eye.The operator was then given a more comprehensive assessment of her eye by an ophthalmologist who prescribed eye drops for her condition.No medical eye patch was needed to facilitate recovery and according to her supervisor, the operator was absent from work for a half day and is recovering well without any lasting effects from the event.The operator has received all required baseline testing (hiv, hepatitis) administered by the hospital due to the biohazard exposure.

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER, INC.; 11800 sw 147th avenue; miami FL 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue, 32-s08; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 5475441
• MDR Text Key: 39524707
• Report Number: 1061932-2016-00215
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 629029
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention